The FDA today approved Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold System, which is the first coronary artery disease stent that is designed to be absorbed by a patient's body.
The FDA today approved Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold System, which is the first coronary artery disease stent that is designed to be absorbed by a patient’s body.
Manufactured from a biodegradable polymer called poly(L-lactide), the Absorb GT1 BVS is inserted in a patient’s artery during angioplasty. After releasing everolimus to limit the growth of scar tissue, the device is then gradually absorbed over approximately 3 years, leaving behind only 4 small platinum markers to indicate where the tube was inserted.
The FDA based its nod on trial data in which the device’s safety and efficacy were evaluated in 2008 patients. After one year, 7.8% of patients who received the Absorb GT1 BVS experienced a major cardiac adverse event rate, which was deemed clinically comparable with the 6.1% rate observed in a control group of patients who were given a more traditional metallic stent. Patients treated with the Absorb GT1 BVS also had a slightly higher yet comparable risk of blots clots (1.54%) compared with those in the control group (0.74%).
“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, MD, director of the FDA’s division of cardiovascular devices division, in a press release.
Adverse events associated with the insertion or use of the Absorb GT1 BVS include allergic reactions to the device materials or medications used in the procedure, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other potentially fatal coronary artery complications that may require medical intervention.
Additionally, the device is contraindicated for patients who have a known hypersensitivity or allergy to everolimus, poly(L-lactide), poly(D,L-lactide), or platinum, as well as in patients who are not candidates for angioplasty, have sensitivity to contrast, or cannot take long-term aspirin therapy along with other blood-thinning medications.